FDA-Drug2021-01-06Class II
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 NDC 69097-529-34
CIPLA
Hazard
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Sold states
U.S.A. Nationwide
Affected count
6,491 packets
Manufactured in
10 Independence Blvd, N/A, Warren, NJ, United States
Products
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 NDC 69097-529-34
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0183-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief